Fixation of Thoracic Epidurals Influencing Catheter-related Infections and Dislocation (TDPAFD)

December 19, 2011 updated by: Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf

Fixation of Thoracic Epidural Catheters Influencing Catheter-related Infections and Dislocation

Major interest in our investigation is to find out whether distinct fixation techniques influence catheter dislocation and/ or incidence of local inflammation. A systematic comparison of two different fixation techniques with regard to catheter location, analgetic potential and signs of local inflammation will be conducted. To ensure identical patients groups allocation will be strictly randomized. Furthermore, both patient groups will receive identical pain medication via the peridural catheter in situ. All catheter tips will be screened microbiologically after removal.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Duesseldorf, NRW, Germany, 40225
        • Heinrich Heine University, University Hospital Duesseldorf, Department of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged > 18 years

Description

Inclusion Criteria:

Patients aged > 18 years and operation with thoracic epidural

Exclusion Criteria:

Refusal of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cather fixation by tunneling and suture
Catheter fixation by adhesive tape

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in catheter position
Time Frame: 4-6 days
Difference in catheter position between day of insertion and day of removal, measured in mm between catheter tip and skin niveau
4-6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary variables
Time Frame: 4-6 days
Analgetic quality, incidence of catheter contamination, signs of local inflammmation and microbiological eamination of the catheter after removal
4-6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaborators

University of Osnabrueck

Investigators

  • Principal Investigator: Peter Kienbaum, Professor, Heinrich Heine University, Department of Anaesthesiology, Chairman: Univ-Prof. Dr.med. B. Pannen
  • Principal Investigator: Martin Beiderlinden, Privatdozent, Department of Anaesthesia, Marienhospital Osnabrueck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 12, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (Estimate)

July 26, 2011

Study Record Updates

Last Update Posted (Estimate)

December 20, 2011

Last Update Submitted That Met QC Criteria

December 19, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-VBTSPK-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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